Immediate Implants in Damaged Sockets With Simultaneous Bone Reconstruction vs. Immediate Implants in Intact Sockets and no Reconstruction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tooth Loss
- Sponsor
- Verdugo, Fernando, DDS
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of individuals with low pink esthetic outcomes as assessed by pink esthetic scores (PES)
- Status
- Enrolling By Invitation
- Last Updated
- 3 years ago
Overview
Brief Summary
To evaluate immediate implant placement feasibility and esthetic outcomes in severely damaged sockets that received simultaneously bone reconstruction (cortical bone shield) and implant placement versus intact sockets that needed no reconstruction and had immediate implant placement.
Detailed Description
The present clinical trial aims at demonstrating facial bone regeneration on sites that presented large buccal bone dehiscences \& vertical bone loss and evaluate the feasibility of performing simultaneous bone augmentation and implant placement, comparing the outcomes with sites that had intact sockets that did not require reconstruction. A secondary objective was to evaluate pink esthetics and marginal bone levels at final follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •individuals 20 Years and older
- •Patients requiring single implants to replace missing teeth to restore masticatory function and esthetics.
- •ASA1 or ASA2 (American Society of Anesthesiologists)
- •Healthy individuals with good oral hygiene and motivation
- •No systemic uncontrolled diseases
- •Not taking drugs known to modify bone metabolism
Exclusion Criteria
- •Individuals with untreated \& generalized severe periodontitis
- •Smokers (\>5 cigarettes/day)
- •Poor oral hygiene
- •Diabetes (HbA1C \>6.5% as cutoff value)
- •Uncontrolled cardiovascular disease
- •Poor overall health (ASA IV)
Outcomes
Primary Outcomes
Number of individuals with low pink esthetic outcomes as assessed by pink esthetic scores (PES)
Time Frame: 12 months
pink esthetics scores (PES) as proposed by Belser et al. Values 0-10 were 10 is the best esthetic outcome.
Evaluate implant placement feasibility & success rate at 12 months
Time Frame: 12 months
evaluate implant success following Karoussis et al. success criteria
Secondary Outcomes
- Number of participants with >0.2mm of marginal bone levels(12 months)
- Band of keratinized tissue: clinical presence or absence(12 months)
- Implant transparency: clinical presence or absence(12 months)